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Perfusion Pack (UDI 00803622133688)Recalls & reported problems

Livanova USA, Inc.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00803622133688), received between Jun 29, 2018 and Jun 29, 2018 — classified as 1 malfunction.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    LIVANOVA RECEIVED A REPORT THAT AIR WAS IDENTIFIED IN THE VENOUS LINE OF THE PERFUSION TUBING SET DURING A PROCEDURE. THE CUSTOMER REPORTED THAT THE SITUATION RAPIDLY BECAME UNMANAGEABLE AND INTERVENTION BY SEVERAL MEMBERS OF THE SURGICAL TEAM WAS REQUIRED TO ATTEMPT TO REMOVE THE AIR. THE AIR COULD NOT BE REMOVED AND THE LINE WAS CLAMPED AND THE BYPASS WAS STOPPED. VACUUM WAS ADDED TO THE LINE TO REMOVE THE AIR AND THE SITUATION WAS NOT IMPROVING UNTIL BLOOD SUDDENLY BEGAN TO FILL THE VENOUS CANNULA AND THE AIR WAS ABLE TO BE REMOVED. BYPASS AND CROSS-CLAMP WERE REMOVED AND THE BYPASS PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7649498 ↗

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.